The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Rateminder V Infusion Pump.
Device ID | K875174 |
510k Number | K875174 |
Device Name: | RATEMINDER V INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Contact | Raymond E Ursick |
Correspondent | Raymond E Ursick CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-17 |
Decision Date | 1988-03-29 |